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Ardelyx Inc

Ardelyx Inc (ARDX)

5.12
0.00
(0.00%)
Closed November 22 3:00PM
0.00
0.00
(0.00%)

Calls

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
1.003.706.003.744.850.000.00 %01-
2.002.705.000.003.850.000.00 %00-
3.001.403.900.002.650.000.00 %00-
4.000.951.650.951.300.000.00 %020-
5.000.350.600.500.4750.048.70 %1581311/21/2024
6.000.150.200.170.1750.0213.33 %6862,07311/21/2024
7.000.050.100.100.0750.05100.00 %21,93111/21/2024
8.000.050.050.050.050.000.00 %044-
9.000.050.450.050.250.000.00 %049-
10.000.000.450.000.000.000.00 %00-
11.000.000.450.000.000.000.00 %00-

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Puts

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
1.000.000.450.000.000.000.00 %00-
2.000.000.450.000.000.000.00 %00-
3.000.050.450.050.250.000.00 %010-
4.000.050.300.100.1750.000.00 %0841-
5.000.300.350.300.325-0.30-50.00 %1801,46511/21/2024
6.000.801.501.451.150.000.00 %01,210-
7.001.702.101.881.90-0.17-8.29 %256011/21/2024
8.001.004.903.502.950.000.00 %010-
9.003.504.300.003.900.000.00 %00-
10.003.805.200.004.500.000.00 %00-
11.004.106.000.005.050.000.00 %00-

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ARDX Discussion

View Posts
Whalatane Whalatane 2 days ago
Jefferies note ...via Frank on X
$ARDX Jefferies reiterated Ardelyx, Inc (ARDX) at a Buy rating and $11 price target.

-Mgmt is confident it can navigate the various Xphozah dynamics going into 2025 and are optimistic underlying patient demand should grow despite pot'l changes w/ Xphozah reimbursement. We'd also flag the CMS litigation is not completely over as mgmt will likely challenge / appeal imminently and there's still a scenario a PI / stay could happen by YE.
We appreciate there's still near term uncertainty but are confident stock can rebound once we're in 2025.
-Mgmt will move quickly to appeal the motion to dismiss...should hear more by YE. The Judge in ARDX's lawsuit against CMS recently granted a motion to dismiss though the case has not been closed. We think ARDX could file a "motion to reconsider" and point out specific flaws in the Judge's logic. The Judge could reconsider and grant a Pl or summary judgement, or if denied ARDX could appeal to the Circuit, which could possibly grant a stay before Jan 1st 2025 given the imminent irreparable harm. All in all, a Pl could still be possible before YE vs our initial belief that this is no longer on the table.

-The House and Senate bills continue to make steady progress in gaining co-sponsors and mgmt thinks a minibus/omnibus bill package could be possible as a vehicle for YE. HR5074 has gained bipartisan support in both the House and Senate and it's likely such a non-controversial bill could move forward before YE to "clear the deck" for a Republican House and Senate next year.

Also note that the initial bill for a bundling delay until 2033 was proposed by Republicans but Dems pushed for a much shorter 2 year delay. Thus, one could argue a Republican majority in the House/Senate could favor add'l bills in the future to delay bundling. ( my comment ...interesting )

-ARDX is also well-equipped and prepared to preserve volumes if Xphozah enters the bundle in 2025. Xphozah reps are out in the field messaging cont'd access and doctor feedback has mostly been (+). That said, docs need to actually go through the process themselves and importantly for substantially higher volumes to gain confidence Xphozah scripts will still be fulfilled.

Medicare scripts will be adjudicated by ARDX's existing patient assistance program Ardelyx Assist and filled at an external specialty pharmacy. Docs are already using the PAP in a small proportion of patients but key is that the PAP will need to be able to handle many thousands of scripts. The PAP has now been expanded in anticipation of greater volumes with all new staffers already hired, trained, and ready for Jan 1st, 2025, and external vendors are also ready to take on add'I patients.

It's also notable ARDX has continuity of care programs in place that will automatically enroll Medicare patients and provide free drug for 2 months....my emphasis ....good move

-Net net, mgmt is optimistic Xphozah won't face significant disruption in 2025 from a volume perspective though investors are understandably cautious.

Kiwi
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Whalatane Whalatane 2 days ago
Interesting ..thx ...might be a plus for the Kidney Patient Act
Kiwi
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Whalatane Whalatane 2 days ago
Well if ARDX's Ceo sticks to his position and refuses to put Xphozah into the TDAPA process ...then UNCY's OLC may be the only new pho binder available to dialysis patients , once it's approved.
Actually any win for ARDX ( Kidney Patient Act passing , extending time line of adjustment period following TDAPA etc ) ...is a win for UNCY also ( at no cost to UNCY )
So UNCY wins either way ...eventually . Now if they can just get their PPS over a $1 and remove the Naz delisting R/S threat , I'll be a happier camper

Kiwi
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rosemountbomber rosemountbomber 2 days ago
Just heard that Dr Oz is going to be head of CMS.  Wonder if it means anthing for ARDX or UNCY?
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Whalatane Whalatane 2 days ago
Hi Free Most of my portfolio is AI related ...NVDA, VRT , VST etc I posted on Biotech Values board recently about APP ...which I assigned to my youngest son when it was $110 ...NEVER expecting its recent run .
Biotechs I like ...RZLT, OCUL , VERA, EWTX ,UNCY etc also had green days .

My feeling about ARDX . I think the Ceo will stick to his current position and wait to see if the Kidney Patient Act gets passed before the EOY. ...which might be a long shot
If it doesn't get enough cosponsors etc and it's pushed into next year ....hopefully he and CMS will negotiate and compromise .

My wife knows of patients on Xphozah who for the first time have been able to get their serum pho to goal . Never happened on the existing binders .
These are Medicare patients that will lose coverage starting Jan ...unless CMS and ARDX compromise ...OR the Kidney Patient act pass's.

I'm betting on an eventual compromise ...as explained in previous posts

Kiwi
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rosemountbomber rosemountbomber 3 days ago
Kiwi. Other than some very small reds in my divvy account, the only red beside ARDX today is CRSP and not much by much.

One thing I find a tiny bit funny is that although the deviations are small, it seems often enough that when ARDX is positive, then UNCY is slightly negative and vice versa. Seems a little odd but it could just be serendipity.
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FreeNorth FreeNorth 3 days ago
Kiwi, what are the non-red winners on your screen :--)
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Whalatane Whalatane 3 days ago
ARDX is the only thing thats red on my screen :--(
Kiwi
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Whalatane Whalatane 3 days ago
RMB. thx for that link . Just watched the presentation .
Ibresla ...expanding sales force , adding new territories , still needs prior authorization ( patient fail first line drug first ) ...but expect mkt to grow

Xphozah ... Hoping the Kidney Patient Act pass's ...5th most looked at legislation currently working thru Congress .
The problem is loss of Medicare coverage starting Jan 1st .
Their non Medicare population is seeing strong up take when covered by insurance ....but non Medicare is only about 40% of the total dialysis population ( at most ) .

They are telling Docs to keep writing scripts for their Medicare patients .
But is IMHO very unlikely MD's will start new Medicare scripts now ...theres at least a 2 wk period where roughly 50% experience diarrhea ...before they adjust to this med ....to only then tell the patient they can't get Xphozah in Jan .
The ARDX assist program doesnt work for Medicare patients ...my understanding .

So Xphozah for Medicare ( 60% of their market ) likely to come to an abrupt end in Jan ( unless the Kidney patient act pass's before then )
If they had applied for TDAPA these patients would still have Xphozah ( and they would make $ for the next 2 yrs with lesser amounts for 3 yrs past that before competing with generics )
But why develop new drugs if U end up having to compete with generics in 5 yrs anyway .
Thats why CMS's plan as currently stands, kills innovation

So its $ stand off game
CMS wants to ultimately limit what they pay for Xphozah by including Xphozah in the bundle in 5 yrs ( 2 yrs TDAPA plus 3 yrs adjusted payments )
ARDX significantly over charges for Xphozah compared to what they charge for Ibsrela ...its the same drug ...but feels its justified due the the cost of the clinical trials etc they have run .

Right now it looks as tho ARDX has no interest in seeking a compromising with CMS ...and rather is betting on the Kidney Patient act and patient / MD advocates . Which may explain todays action

A compromise would be ARDX lowering the price per gm of Xphozah to that of Ibsrela ...in exchange for a longer time period before entering the dialysis bundle


Kiwi
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rosemountbomber rosemountbomber 3 days ago
Guess the market didn't think much of the presentation or thinks there is no way Kidney Act passes.  Gonna give Mott a call.  
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rosemountbomber rosemountbomber 3 days ago
Kiwi. Listened to the CC this morning. Company seems staunch in their belief that they will be able to continue growth of Xphopah (sp?) albeit whilst taking a bit of hit to revenue. They are in touch with docs and say that the docs are quite aware of the coming situation. https://wsw.com/webcast/jeff315/ardx/1849260
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rosemountbomber rosemountbomber 4 days ago
Ha. Not me. Would be nice to know Mott's net worth to know how important his investment here is
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Whalatane Whalatane 4 days ago
There was a million share buy order that went thru ...I figured that was U ..:--)
High risk so buckle up
JMO
Kiwi
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rosemountbomber rosemountbomber 4 days ago
I did the same Kiwi this am
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Whalatane Whalatane 4 days ago
RMB. I added this am
My take for what its worth
1) It will be tough to get the Kidney Patient Act passed before EOY . It needs to get added on to something like the Govt continued spending bill with more co sponsors . No impossible but a real challenge
2) DaVita and other dialysis centers are preparing for the shift to storing and dispensing Oral pho binders on site .
Some Nephrologists welcome this as it means they can be sure the patients get these meds . Currently there are problems with pharmacies filling only 1 mth at a time when the patient ask's for a 3 mth fill . If these meds can't be mail ordered the patient often miss's the 1 mth pharmacy pick up .
Dialysis center managers are less enthused ...big hassle for them to order , store , manage supplies .
3 ) For those on Medicare getting Xphozah ..... access to X may be very limited in Jan 2025 forward ...so some thoughts on prescribing Ibsrela instead as discussed in a previous post .
If so we should see an uptick in Ibsrela scripts in early 2025 ...although ARDX will be making less $ then if it were a Xphozah script ...even tho its the same drug
4) Ibsrela scripts for dialysis patients who don't have IBSC would obviously be an off label script . While this practice ( writing off label scripts ) may be frowned on ...it's not uncommon. ( I had an off label script for Vascepa before the R-IT approval for the CAD indication )
5 ) Theres going to be pressure from Nephrologists and patients for a compromise to be worked out here .
Some patients are now able to get their serum pho levels to goal on Xphozah ...where as they couldn't previously on the existing binders .

ARDX can lower the price of Xphozah to be similar to price per gm of Ibsrela in exchange for a longer runway before having to compete with generics
Currently its 2 yrs in TDAPA , then 3 yrs of price adjustment , then compete with generics
They can adjust that to something like 2 yrs in TDAPA , then 6 yrs in gradual price adjustments , then compete with generics

Just my thoughts ...we'll see how they age :--)
Kiwi
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Whalatane Whalatane 4 days ago
Yep thats my take . If it's not enough to get to goal ( each patient responds differently ) add a generic Renvela ( which is cheap ) .
They are testing X in combo with Renvela already .
Bottom line ...there are work arounds if MD's are willing to prescribe off label even tho its the same drug .
Incentive for ARDX to make a deal with CMS and keep everything kosher .
The problem patients have with Renvela is the pill load 2-3 per meal
1 in the am with half a Ibrsela and the same in the pm ....probably the same serum pho lowering as a full daily dose of Xphazoh ...for 1/3rd the cost

Kiwi
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rosemountbomber rosemountbomber 4 days ago
Real quick.  Getting 50mg by splitting basically 1159, so significantly cheaper but 10 mg less
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Whalatane Whalatane 5 days ago
RMB. Can U chk my math on this ...thx ...I'd posted on Dews board

Ibsrela and Xphozah are the same drug ...Tenapanor
Ibsrela is for the IBSC indication ...50 mg twice a day = 100 mg of Tenapanor a day
Xphozah is for dialysis patients ...30 mg twice a day = 60 mg a day

A 80 day supply of Ibsrela without insurance is quoted at $2,317
A 80 day supply of Xphozah without insurance is quoted at $4,284

So ARDX is charging dialysis patients / Medicare almost twice as much..... for just over half as much ...of Tenapanor per 80 day period ?

The reason this comes up is that since ARDX is not entering the TDAPA process ...dialysis patients on Medicare ( majority of them ) will lose access to Xphozah starting Jan 1st 2025.
Since some of these patients currently on Xphozah have been able to lower their serum pho levels to goal ....for the first time ( never got there on the existing pho meds ) .....theres some concern about what happens for these patients Jan 1

Now a work around being " whispered " ...is simply to prescribe these dialysis patients Ibsrela instead ...its the same dug and ARDX is charging a lot less for it .
If they prescribe 1 pill of Ibsrela ( 50 mg ) plus a pill splitter ... so 25 mg twice a day ...they get close to the 30 mg twice a day ( 60 mg ) ...for roughly $1,200 ( without insurance ) vs the $ 4,284 ( without insurance ) ARDX is currently charging .

My first run thru on this so I'd appreciate it if others here chk'd my math
Thx
ARDX Chairman of the BOD David M Mott made a very large open market purchase of the stock this week

Kiwi
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rosemountbomber rosemountbomber 5 days ago
Sounds plausible.  Wonder if there are examples where Medicare is that amenable.  But have to assume that Mott is not so stupid as to plop that much down on something heading down a dark tunnel.  Although I added last week I may think about throwing a few more dollars at this if I can free some up elsewhere, but nothing excessive.  Good luck to us all. 
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Whalatane Whalatane 5 days ago
RMB well I'm hoping CMS and ARDX compromise over Xphozah
ARDX can lower the price of Xphozah to be the same per gm as they charge for Ibsrela ...its the same drug Tenapanor
CMS can extend the time period before Xphozah is forced to compete with generics in the dialysis bundle .

So what might force this compromise ?
As it currently stands Medicare patients on dialysis will lose access to Xphozah on Jan 1st as ARDX has not entered the TDAPA process ...which as currently set up would mean X having to compete with generics in the dialysis bundle within 5 yrs .

Meanwhile some dialysis patients who were never able to lower their serum pho levels to goal on the current pho meds ....have been able to on Xphozah .
So there are now some " whispers " in the Nephrology community suggesting that if Xphozah is not available ....just prescribe Ibsrela ...since it is the same drug ( just different dose levels for IBSC patients )

This would probably be an " off label " script since even tho its the same drug ...Tenapanor ....it's for a different indication IBSC

ARDX is over charging dialysis patients / Medicare as I've stated before .
The price for Xphozah is roughly 40%-50% more per gm then what they charge for Ibserla ....even tho its the same drug
They can lower the price to match Ibsrela per gm in exchange for a longer runway in price adjustments following TDAPA before they have to compete with generics in the dialysis bundle .

I think that where this is going and the only reason IMHO for Mott who is chairman of the BOD would make such a large open market purchase last wk.

JMO
Not investment advice
Kiwi
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rosemountbomber rosemountbomber 5 days ago
Thanks for all that insight Kiwi.  Have to assume Mott knows something about the path they will take going forward. I would feel better if the Kidney Act passed Congress. . 
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Whalatane Whalatane 5 days ago
RMB. yes I think so . re Insider Mott ...Chairman of the BOD large insider buy
An update . My wife prescribes these med ( serum pho lowering ) to her dialysis patients . We were on a drive today and normally she doesnt like to talk much about work related issues ...but trapped in a car with me for an hr or so she relented .
Her view is that Xphozah is way over priced ...something I agree with when U compare to what ARDX charges for Ibsrela ...same drug ...for IBSC
She does acknowledge that it works ...one patient in particular with high serum pho levels on the available meds was able to lower pho levels to goal.. on Xphozah .
Patients on current pho meds complain of constipation so since Xphozah causes diarrhea for some ...and a loose stool for others ....there is an interest in trying X to not only reduce pho when the other meds don't ...but for some to also give them more normal bowel mvts.

She would prefer these meds to be distributed by the clinics she rounds so as to be sure the patient actual got the med . To often there are issues with the pharmacy wanting a reauthorization every mth !!!
There is real concern about starting dialysis patients on Xphozah now ...when it may no longer be covered for Medicare patients in Jan

The current process is for the new oral pho drugs to start TDAPA in Jan ...so would be covered for 2 yrs ...then at a reduced rate for 3 yrs after that ...and then finally have to compete with generics in the dialysis bundle when the full 5 yrs was up .
I think theres a consensus developing that no new oral pho drugs will be developed going forward...if they are forced to compete with existing generics in 5 yrs

ARDX can lower the price of Xphozah by about 1/3rd to cost the same per gram as Ibsrela ( it's the same drug ) ....and I speculate they may do that in exchange for more years at higher pay out coverage .
This is similar to what happened with the launch of Repatha ( I drug I take )
On launch it was $14,000 a yr and few scripts were approved .
2 yrs later after extensive negotiations they lowered the price to around $6,000 a yr in exchange for easier script approvals
Where as I was previously denied this drug even tho I meet all the profile requirements ...I can now get it for a $1,800 a yr copay ( $150 a mth )

I think / hope they will do something similar with Xphozah and UNCY's OLC ....and was buying both back on Friday
JMO
Not investment advice
Kiwi
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rosemountbomber rosemountbomber 6 days ago
Wonder what his thinking is.  Does he think even without passage of Kidney Act that there is still a path forward for ARDX?
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Whalatane Whalatane 7 days ago
Big bet by an insider ...open market purchase David M Mott
http://archive.fast-edgar.com/20241114/AWZZ3Q2COZ22UZ3Z2C9N2ZZ2P4KUZ22IZY62/


David M. Mott is a prominent figure in the biotech investment landscape, with a long and successful career spanning over three decades. Here's an overview of his biotech investments and career:
Investment Career
David Mott is currently a private investor through Mott Family Capital12. Prior to this, he served as a General Partner at New Enterprise Associates (NEA) from 2008 to 2020, where he led the healthcare investing practice25. During his time at NEA, Mott oversaw $1 billion in health care venture capital8.
Board Positions
Mott holds several chairman positions in biotech companies:
Chairman of Adaptimmune since January 20174
Chairman of Ardelyx, Inc. since 200812
Chairman of Mersana Therapeutics since 201312
Chairman of Novavax, Inc. since June 20202
He previously served as chairman for Epizyme and Imara, Inc.12
Notable Investments
Throughout his career, Mott has been involved in numerous biotech investments, including:
Sagimet Biosciences
Cydan
Nightstar Therapeutics
Vtesse
XTuit Pharmaceuticals
Clementia Pharmaceuticals3
Industry Experience
Before his investing career, Mott held executive positions at MedImmune:
President and Chief Executive Officer from 2000 to 2008
Various roles including Chief Operating Officer and Chief Financial Officer from 1992 to 200012
During his tenure at MedImmune, Mott led the sale of the company to AstraZeneca in June 2007 for $15.6 billion1.
Investment Impact
Mott's expertise in the biotech sector has led to significant achievements:
Involved in more than $40 billion in corporate acquisitions, fundraising, and partnerships
Supported over 35 initial public offerings or corporate acquisitions
Brought more than a dozen new drugs through development to commercialization
Served on 25 corporate boards1
David Mott's extensive experience and successful track record have established him as a key figure in biotech investing, with a particular focus on venture capital and growth equity investments in the healthcare sector.


Kiwi
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Whalatane Whalatane 7 days ago
From Frank on X re Kidney Patient Act
$ARDX H.R.5074 added two more co-sponsors yday
-Rep. Hayes, Jahana [D-CT-5] 11/14/2024
-Rep. Pingree, Chellie [D-ME-1] 11/14/2024

Kiwi
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Whalatane Whalatane 1 week ago
Ardelyx Insider Bought Shares Worth $996,598, According to a Recent SEC Filing
MT Newswires

Kiwi
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Whalatane Whalatane 1 week ago
Jefferies report out ...Think theres a chance the Kidney Patient Act bill will be added onto one of the must pass bills before end of yr ( Govt spending bill etc ) and even if not , Ibsrela scripts are growing and they will still make $ off non Medicare Xphozah patients .
Apparently 2 more cosponsors also added to the KP Act
Kiwi
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rosemountbomber rosemountbomber 1 week ago
Why did this turn around today?  Passage of kidney bill increasing chance?
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Cosa Cosa 1 week ago
Well I guess there is no 3rd time this year. Market cap dropped to $1.07B. Uncertainty with CMS really weighing this down.
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rosemountbomber rosemountbomber 1 week ago
Don't know if there is another bill that has any many signers/co-sponsors/whatever they call it, so hopefully it happens.  
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Whalatane Whalatane 1 week ago
RMB re Wainwrights downgrade etc . The current position of CMS means that although patients may have access to the new serum pho lowering drugs ...the dialysis providers are unlikely to prescribe them .
The reason is the way the dialysis bundle works .
CMS has agreed to pay around $273 per dialysis and the way the contract with providers work ...providers get to keep whatever $ are left over between what CMS pays and what it costs them ...per dialysis

So the dialysis providers will make more $ if they continue prescribing the existing generic serum pho drugs .
Theres no $ incentive ( or $ neutral way ) to prescribe the new serum pho lowering drugs even tho they may be better for the patients .

The only hope of changing this it appears ...is the Kidney Patient Act working its way thru Congress

Kiwi
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Mr.Mister Mr.Mister 2 weeks ago
That and possibly HC Wrainright downgrade. HC W is the most optimistic analytical firm to boot
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rosemountbomber rosemountbomber 2 weeks ago
Tanking again this morning possibly because UNCY's drug got accepted for review by FDA
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Whalatane Whalatane 2 weeks ago
https://kidneycarepartners.org/press/kidney-care-partners-supports-policies-to-expand-home-dialysis-and-improve-reimbursement-for-phosphate-lowering-drugs-remains-concerned-cms-has-not-addressed-barriers-to-patient-access-to-innovative/

Kiwi
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Whalatane Whalatane 2 weeks ago
Also beginning Jan. 1, 2025, the bundled payment will include oral-only renal dialysis drugs and biologics โ€” a move initially set to begin in 2014 but delayed until now by several laws and court challenges.

โ€œIn response to comments that we received on the proposed rule [released in July], we are finalizing a policy to pay the [transitional drug add-on payment adjustment] for phosphate binders based on 100% of the average sales price, increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a [transitional drug add-on payment adjustment] payment for phosphate binders. We expect that incorporating oral-only drugs and biological products into the [End-stage Renal Disease Prospective Payment System] will increase access to these drugs,โ€ CMS stated in the release.

In a response statement, Kidney Care Partners (KPC), a non-profit coalition of stakeholder organizations, expressed concern that โ€œthe base rate is insufficient to support adding new treatment options without adding new money.โ€

โ€œWe applaud CMSโ€™s efforts both in recognizing that providing oral-only medications as part of the bundle requires additional funding, as well as creating access for AKI patients to home dialysis,โ€ Mahesh Krishnan, MD, MPH, MBA, chair of Kidney Care Partners, said in the statement. โ€œHowever, KCP has consistently raised concerns that significant changes are needed to the ESRD PPS system to maintain an appropriate level of care, access and reimbursement for the more than 557,000 Americans who rely on regular dialysis treatment.โ€

KPC urged support of the Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S. 4469) to provide a permanent reimbursement pathway for innovative drugs and devices.

Kiwi
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ErnieBilco ErnieBilco 2 weeks ago
That's why I pay attention to your posts.

I'm just lurking in the background until it really corrects, if it ever does.
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aBeezlee aBeezlee 2 weeks ago
Going against CMS was unlikely to end in success, sadly. This still sucks cause wtf. Corrupt country to the bone.
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Whalatane Whalatane 2 weeks ago
Ernie. Not a complete surprise . I posted this opinion some time ago

Monday, October 07, 2024 11:17:05 AM
Post# of 1648
Likely reason for sell off ...CMS likely to prevail


Richard Cantillon
@cantilloncap
ยท
36m
My best guess is CMS wins and Court declines motion for prelim. injunction & sets a new schedule for MSJs. A better bet is HR5074 but I think we need 50 co-sponsors to really feel comfortable here. $ARDX

Always thought the Kidney Patient Act has a better chance ( but obviously no guarantee )

Kiwi
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ErnieBilco ErnieBilco 2 weeks ago
Ardelyx (NASDAQ:ARDX) plunged 17% after a court dismissed a lawsuit the company filed against the Centers for Medicare and Medicaid Services (CMS) over its proposal to bundle its kidney disease therapy Xphozah in the Medicare payment system applicable for dialysis services.

"Defendantsโ€™ motion to dismiss is therefore granted, and plaintiffsโ€™ motion for a preliminary injunction or expedited summary judgment is denied as moot," US District Judge Beryl Howell wrote in an opinion.

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In October, the FDA approved Xphozah as a late-line add-on therapy to cut serum phosphorus in adults with chronic kidney disease on dialysis.

The issue relates to Medicareโ€™s plan to include Xphozah, along with all other oral-only phosphate-lowering therapies (PLTs), in its End-Stage Renal Disease Prospective Payment System (ESRD PPS), a bundled payment system for dialysis services.
Ardelyx (ARDX) didn't immediately respond to Seeking Alpha email request for comment.

The decision, which will take effect on January 1, 2025, can potentially eliminate Part D coverage for Xphozah.

The plaintiffs alleged that the Medicare proposal violates U.S. law, noting that dialysis providers do not administer Xphozah and other PLTs, currently offered under outpatient pharmacy benefit plans such as Medicare Part D.
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ErnieBilco ErnieBilco 2 weeks ago
What we think about ARDX on 11/01/2024 MarketEdge
Stock is a Short Sale Candidate.
If you are Long; close position or monitor stock closely.
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Mr.Mister Mr.Mister 2 weeks ago
how much do you reckon uncy will charge?
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Mr.Mister Mr.Mister 2 weeks ago
how much do you reckon uncy will charge?
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rosemountbomber rosemountbomber 2 weeks ago
Almost 5 million shares traded in first half hour.  
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rosemountbomber rosemountbomber 2 weeks ago
Bug drop and seeing posters elsewhere saying court case has been dismissed. Only hope now is Kidney Act.  Disaster du Jour. 
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Whalatane Whalatane 2 weeks ago
Mr Mister To the best of my knowledge , generic Renvela is the serum pho drug most prescribed to dialysis patient .
It cost about $1 per capsule and most patients need 2-3 with each meal ...so $6- $9 a day ...... max of $270 a month
Most patients don't like Renvela ( it does work at the prescribed dose ) because it's usually 2- 3 large pills with every meal ....and most patients can't stick to that so serum pho levels are usually higher than they should be .

UNCY's OLC if ever approved , is one small pill with each meal and for Medicare patients should only cost roughly $ 60 more per month

ARDX's Xphazoh ...2 small pills per day .... will be at least $300- $400 more per month for Medicare patients as currently priced . ( about $200 more per mth if priced as per Ibrsela )

JMO ...based on the info I have access to

Kiwi
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Mr.Mister Mr.Mister 2 weeks ago
Until or unless binders start working for people, Xphozah has no commerical or competitive reason to reduce their prices. That may change if or when UNCY finally gets its OLC approval but that isn't expected until the middle of next year.

There's also no guarantee UNCY won't charge a premium for its product.

But time will tell and may eventually prove you right
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Whalatane Whalatane 2 weeks ago
MrMister. It's a dumb pricing move IMHO .
If the FDA accepts UNCY's NDA ( the decision appears imminent ) and UNCY's OLC eventually gets approved .....Nephrologits and their patients will have a choice
Xphozah at around $3,000 a month or OLC at around $1,300 a month ...the Medicare patient copay is usually around 20-30% of these costs
OLC will be substantially cheaper ...AND is actual more effective at lowering serum pho ( although requires 3 small pills a day vs 2 for X and has different side effects )

Kiwi
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rosemountbomber rosemountbomber 2 weeks ago
So crazy.  How can a stock be up over 13% one day and down 5% in premarket the next on no news!
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Mr.Mister Mr.Mister 2 weeks ago
You're allowed to object. You're not allowed to tell them what to charge, especially after the long regulatory approval road the FDA put them on. Had the FDA given them a broader label, maybe they would have priced it more similarly to the binders it competes against or supplements.

As it stands, Xphozah is priced to the allow the company to recoup its time and investments. I applaud Ardelyx for not allowing CMS to destroy its prospects
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Whalatane Whalatane 2 weeks ago
MrMister I object to the premium ARDX is charging for Xphozah compared to what they charge per gm for Ibresla ...its the same drug Tenapanor .
Most on dialysis are on Medicare and have limited income . They are in a dialysis chair 4 hrs a day for 3 days a week . Since they are on Medicare they can't use any coupons .
At most Medicare will pay about $2,400 of the monthly cost with the patient paying the remaining roughly $700

How many of my wife's Medicare dialysis patients can afford the roughly $700 a month copay for Xphozah ......Zero .

So yeah ...I object to their pricing

Kiwi
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